Table 2. Number and percentage of studies reporting external validity elements 1.
External validity dimension | Definition | Studies
reporting |
|
---|---|---|---|
Yes/Total 2 | % | ||
Reach and representativeness of individuals | |||
Target population for generalizability | Is the intended target population acknowledged/stated (at the individual level)
for which the findings intend to be generalised to? |
38/39 | 97 |
Method to recruit target population | Was information provided about how the target population was recruited/
reached (e.g., radio, newspaper, TV, school meeting)? |
30/39 | 77 |
Inclusion or exclusion criteria | Were individual inclusion and exclusion criteria stated? | 38/39 | 97 |
Enrolment rate | Is the enrolment rate or data needed to calculate the enrolment rate among
individuals reported? Proportion of people who are eligible for participation who actually enrol in the study |
26/39 | 67 |
Recruitment rate | Is the recruitment rate or data needed to calculate the recruitment rate among
individuals reported? Proportion of potential participants (those invited or expressing interest) who actually enrol in the study |
26/39 | 67 |
Representativeness of individuals | Are there comparisons between individuals who participated versus either (1)
those who declined to participate or (2) target population? |
10/39 | 26 |
Participant characteristics | Are all of the following reported:
•Gender •Age •Any socioeconomic indicators (education, employment status, or income) •Participation by racial or ethnic minority groups |
21/39 | 54 |
Reach and representativeness of settings | |||
Target setting | Is the target setting for intervention delivery stated (such as workplace, general
practice, outpatient facilities, churches, etc.)? |
35/38 | 92 |
Method to recruit setting | Is information provided about how the site(s) within a given setting were
recruited/reached to participate in delivering the intervention? |
4/28 | 14 |
Inclusion or exclusion criteria | Were inclusion and exclusion criteria for selection of sites within a given
setting stated? In the case of single sites, were the characteristics of the site described? |
6/28 | 21 |
Participation rate | Is the participation level or data need to calculate the participation level among
eligible sites reported (only applies to studies with more than one site)? |
1/19 | 5 |
Representativeness of setting(s) | Are there comparisons between site(s) participating in the intervention and 1)
those that decline to participate or 2) the target setting? |
1/28 | 4 |
Implementation and adaptation | |||
Intervention characteristics | Were the intervention components described? | 38/39 | 97 |
Intervention adaptation | Is information reported about how the study intervention is similar or different to
original efficacy studies? Note: Only applicable to studies where an intervention is adapted from a previous trial |
0/5 | 0 |
Time to deliver intervention
described |
Is the number and length of sessions or time required to deliver the intervention
described? |
24/37 | 65 |
Intervention delivery and exposure | Was the extent to which individuals were exposed to the intervention
described? (e.g. proportion of planned intervention sessions actually attended (dose); content delivered as specified; provider adherence to intervention plan) |
24/37 | 65 |
Delivery agents: characteristics and
training |
Is information provided on who delivered the intervention, such as the type of
professional, or the amount of experience, skill or training required to deliver the intervention? |
37/39 | 95 |
Methods to recruit delivery agents | Is information provided about how the delivery agents were identified/selected? | 3/36 | 8 |
Delivery agents’ participation | Is the participation level amongst delivery agents reported (% of delivery
agents agreeing to participate)? |
4/35 | 11 |
Fidelity assessment: treatment
receipt |
Is information reported about whether the program was received as intended?
(e.g. degree to which the participants understood the intervention and/or ability to perform the intervention skills) |
4/39 | 10 |
Mechanisms for intervention effects | Was retrospective analysis conducted to identify the mediating variables
through which the intervention achieved its effect? |
2/39 | 5 |
Outcomes for decision making | |||
Outcomes that can be compared to
standards |
Are outcomes (at least one) reported in a way that can be compared to either
clinical targets or public health goals? |
36/39 | 92 |
Adverse consequences | Does the article report whether they examined the occurrence of unintended
consequences? |
18/39 | 46 |
Effect moderators by participant
characteristics |
Are there any analyses of moderator effects by subgroups of participants | 10/39 | 26 |
Effect moderator by delivery agent/
setting |
Are there any analyses of moderator effects by delivery agents or settings | 0/37 | 0 |
Dose response effect of intervention
(sensitivity) |
Are there sensitivity analyses to assess dose-response effects of the
intervention? |
1/39 | 3 |
Total costs of intervention | Are total costs of the intervention presented? | 6/39 | 15 |
Cost of intervention components | If costs are presented, were the costs itemized by intervention components
(e.g., personnel, equipment)? |
4/6 | 67 |
Cost effectiveness | If costs are presented, was there any analysis done to assess cost-
effectiveness or cost-benefit of the program or policy? |
3/6 | 50 |
Maintenance / institutionalisation | |||
Long term effects (at least 12
months) 3 |
Are data reported on longer term effects on health-related outcomes, at least 12
months following program implementation, or environmental or policy change? |
19/39 | 49 |
Institutionalization: sustainability /
plans for sustainability |
Are data reported on the sustainability (or reinvention or evolution) or plans for
sustainability of the intervention? |
4/39 | 10 |
Attrition | Are data reported on the number of individuals dropping out and/or lost to
follow up |
38/39 | 97 |
Differential attrition (by condition or
population sub-group) |
Are data on attrition by condition or population sub-group reported? | 35/39 | 90 |
Representativeness of completers/
dropouts |
Did the study report statistically significant differences in those that dropped out
of treatment and those that finished? |
19/38 | 50 |
Acceptability of the intervention by
stakeholders |
Was information provided about acceptability of the intervention by
stakeholders? |
14/39 | 36 |
Notes:
1Laws et al. (adapted from Green et al.)
2Total = the no. of overall studies (n=39) minus the no. of studies reporting not applicable to the relevant element
3In RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), long-term results of intervention are defined as a minimum of six months following the last contact; long-term is defined as a minimum of 12 months by Laws et al.